Define the life cycle of a medical device.
If so, how does it differ?
A medical device can be described as an implement, machine, instrument, machine, app, implant, software or material that is intended for in-vitro medical use by the manufacturer company. It may include a medical device, implement, machine and apparatus.
Medical devices can be simple or complex, such as a thermometer and a bedpan or programmable pacemaker.
Diagnostic products, such as equipment for laboratory purposes, test kits, and reagents, may also be included in medical devices.
The process of developing a drug to treat a specific weakness in a cell is known as drug development.
Pre-clinical research and trials in humans are part of the drug development process.
This report will discuss the development and testing of medical devices.
This report will compare the process of developing a medical gadget with drug development methods, including the life cycle for medical equipment.
The Life Cycle of a Medical Device
The Lifecycle of a medical device generally includes
Research: This includes clinical trial controls, good laboratory practices, and exemptions for investigational devices.
Design and Development: This requires design control, good laboratory practices, document control, and electronic records.
FDA approval or review: This requires 510(k), clearance, PMA (produce marketing association) and document control
Manufacturing and services: This includes requirements for Quality Systems, Establishment Registration, Labeling Control, Design Control, Recall, Complaints, and Reporting of Medical Devices
Obsolescence includes records and retention.
The Development of a Medical Device
You can develop a medical device in 5 steps
This is the first step in developing a medical device.
The classification process follows, which governs the majority of aspects of device development.
The device type and risk assessed are the criteria for classification. This is different in the United States than it is in the United Kingdom.
This step involves prototyping a device.
The device is not ready for human use until this stage.
The prototypes will then be tested in the lab using both in-vitro as well as in-vivo methods.
These tests give data about the device’s safety and effectiveness.
Screening for potential carcinogenicity in the reproductive health of an individual can be done by genetic and reproductive toxicology screens.
The preclinical stage is completed and humans trials are initiated.
These trials are broken down into phases that differ from drug-related trials
Phase A. Pilot or Explanatory Phase
Studies that involve ten to thirty patients are designed to assess the safety and performance of the initial treatment.
To determine the clinical efficacy of adverse situations and to search for them, studies involving 150 to 300 participants are conducted.
Even after the medical device is released to the public, studies continue on the device.
This phase has seen the evaluation of long-term safety data and efficacy data.
These studies can be very helpful for devices such as prosthetic implants. However, it might take some time.
It is crucial to determine if any adverse events that might occur during the clinical trials can be attributed to the device being tested.
These are known as SAEs (Serious Abverse Effects). Any device defect should be reported to the regulatory body.
Review of regulations
This phase presents the relevant authority with the data collected during the clinical phase.
This phase is the most crucial. It determines whether the device will be put on the market or not.
The manufacturer can return to the previous steps to make a stronger application for resubmission if the device is rejected.
As long as the device is in use, it’s not possible to complete its development.
As a prolongation of clinical research, the post-marketing surveillance stage is possible.
After a product has been released to the public, the device developer will continue to collect data and regulate the device.
Long-term data may prove useful for medical decisions and future development of a medical device.
Process of Drug Development
Discovery and development
This step is where researchers uncover a new drug using new insights into the process of a disease to create a drug that reverses the effects of a particular disease. They do this by using existing treatments and some tests on a molecular compound.
Once the compound has been identified, researchers carry out experiments to collect information about the drug’s absorption, distribution and metabolism.
Information about the potential benefits, the best dosage, the best route of administration, side effect information, and how it affects different groups such as gender and race.
It is important to determine the potential serious side effects of the drug before testing it in humans.
Two types of preclinical researches will be done in this step: one is in vitro, and one is in-vivo.
Good lab practices are essential for this step.
Clinical research refers to studies that are related to human trials.
This includes sub-stages like clinical research, FDA assistance, FDA review and approval.
Phase 2 of clinical research includes:
The drug is administered to 10 to 100 participants with a disease or health condition.
After the small-scale study,
This stage is used to test hundreds of people suffering from the disorder.
This can take months or even years.
This state is used to determine the effectiveness and side effects of the drug.
This step was failed by up to 70% of drugs.
c. Study of 300-300 people who are healthy or have the disorder.
This process can take up to four years.
This step is where 65 to 70% of drugs fail.
This study is intended to determine the effectiveness and regulation of adverse reactions to the drug.
This step is performed on thousands of patients with a diseased condition.
This step is designed to ensure that the drug is safe and effective.
Investigative new drug process
Before any clinical research can begin, the developers must submit an IND application to FDA.
FDA members can ask for FDA assistance in order to receive help with the drug development process.
The developers must file a new drug application (NDA) after the clinical phase. This application is for the marketing permission of the drug.
During this stage, all data submitted by developers is reviewed or examined by FDA staff who make the final decision about whether or not the drug should go ahead.
The NDA application tells the entire story about the drug.
The NDA application is used to prove that the drug is safe and effective in a particular population.
FDA regulates post-market drug safety
FDA can review reports about problems with prescriptions of drugs and add precautions to the drug.
FDA members inspect drug development facilities on a routine basis.
This inspection is necessary to identify any problems that may arise after the drug has been used.
This step is necessary to make sure that manufacturers follow the GMP (good manufacturing process).
FDA may stop the production of a drug if it is determined that the minimum standards are not being met.
It is forbidden for manufacturers to promote the drug prior to its approval.
FDA has established several programs to allow consumers and developers to report any issues with the drug.
MedWatch and MedSun are two examples.12
There are differences and similarities between drug development and device development
The device development process is very similar to pharmaceutical drug development. However, it differs in that the device includes software and hardware. Drugs are always therapeutic. But the device can be supporting, surgical, diagnostic, or therapeutic.
The body quickly metabolizes the drugs, which have long-lasting effects.
Devices implanted into patients’ bodies may experience some dynamic changes in function and safety.
Research begins the life cycle of a medical instrument and ends at its obsolescence stage.
Other stages include design and development, FDA review, manufacturing and services.
It is possible to see that drug development and device development are almost identical, but differ in certain ways.
Device development involves discovery, preclinical research, clinical research and regulatory reviews. These steps are very similar to those involved in drug development.
Document on the Internet: Medical device. World Health Organisation, 2018. [cited 2018 June 23,].
Is the product a medical instrument?
[Document on Internet]: US Food and Drug Administration. 2018 [cited 2018 Jun 23].
Document on the Internet: Drug development. Nature; 2018. [cited 2018 June 23].
Integrated sustainable lifecycle design: A review: Journal of Mechanical Design: 2010, 132(9).
Fiedler. David BA. Chapter 1 – Reframing the product life cycle of medical devices: New York, USA: Managing medical device within a regulatory framework.
Understanding the five phases of medical device design [document on the Internet] by GreenLightGuru. 2018 [cited 2018 June 22,].
Five stages in medical device development [document on Internet]: Premier Research; 2017. [cited 2018 June 22, 22].
Pontius N. The ultimate manual for medical device design and construction: From discovery and concept to design controls and quality assurance [document on the Internet] Pannam Imaging; 2017. [cited 2018 June 22].
Preclinical cancer research requires drug development to raise standards: Nature, 2012, 428 (7391): 531.
The drug development process [document available on the Internet]: US Food and Drug Administration, 2018. [cited 2018 June 22].
Part 1: Drugs, devices and the FDA: An overview of drug approval processes: JACC: Basic to Translational Science: 2016 1(3): 170-79.
Carpenter, D., Chattopadhya J., Nall C. The complications associated with controlling agency time discretion FDA review deadlines & postmarket drug safety: American Journal of Political Science: 2012,56(1):89-114